FDA Investigates Structure/Function Claims

The Government Accountability Office and the U.S. Food and Drug Administration (FDA) recently released a report in responses to growing concerns about dietary supplements and their structure/function claims. In this report, FDA acquired 127 supplements, analyzed their structure/function claims and investigated how they substantiate such claims.

The dietary supplements under review included 60 weight-loss products and 67 immune-support products. The supplements were purchased in five major U.S. cities from either retail stores (such as pharmacies, supermarkets or supplement retailers) or online stores. FDA reviewed notification letters that supplement companies must file to make claims, and compared them with what those made on the product label.They also alimed to analyze the substantiations from manufacturers for all of the claims, but were only able to obtain them for 72 supplements.

Overall, FDA found many claims on the weight loss supplements that suggested reducing or burning fat, increasing metabolism, suppressing appetite and overall weight reduction. For the immune-support supplements, claims were made surrounding free radicals or antioxidant properties, increasing antibody production and supporting general immune function. FDA felt of these statements were disease claims, while others, the agency said, were not backed up by appropriate evidence. Out of 127 supplements, nine were missing the required FDA disclaimer on their labels and 26 displayed prohibited disease claims. "These results raise questions about the extent to which structure/function claims are truthful and not misleading," the agency stated.

After reviewing the substantiation information, FDA found only 34% were derived from human studies, which is the recommended form for testing products. Out of those human studies, none met all of the FDA recommendations for competent and reliable evidence. Furthermore, only 2% of the studies used the actual product (most were on the active ingredients). Many of the remaining evidence submitted was considered either background information or had no significance in supporting the claims.

The Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) immediately responded to this report. NPA stressed that this study should not taint the entire supplement industry. More than 50% of Americans safely take supplements every day, the group said, and the 127 products reviewed do not show a fair representation of the estimated 29,000 products on the market. CRN was concerned that supplement companies are not “meeting their obligations under law,” and were unhappy with the lack of supporting science. They also wanted to remind consumers to always be smart about shopping for supplements.